Composite prosthesis with external polymeric support structure and methods of manufacturing the same

• US 8,696,738 B2
• Filed: 05/20/2010
• Issued: 04/15/2014
• Est. Priority Date: 05/20/2010
• Status: Active Grant

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Inventors: Noesner, Matthew, Dong, Jerry
• Primary Examiner(s): Stewart, Alvin J.
• Application Number:
  US12/784,393
• Publication Number:
  US 20110288628A1
• Time in Patent Office: 1,426 Days
• Field of Search: 623/1.32, 623/1.33, 623 15- 154, 606191-194, 606/153, 606/154, 606/157, 606/158
• US Class Current: 623/1.32
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0046 differing in melting temperature
• CPC Class Codes: B29C 65/02 by heating, with or without pressure
• CPC Class Codes: B29C 66/006 Preventing damaging, e.g. of the parts to be joined B29C66/003, B29C66/004, B29C66/348 take precedence
• CPC Class Codes: B29C 66/532 Joining single elements to the wall of tubular articles, hollow articles or bars
• CPC Class Codes: B29C 66/712 the composition of one of the parts to be joined being different from the composition of the other part
• CPC Class Codes: B29C 66/723 being multi-layered B29C66/7292, B29C66/72941 take precedence
• CPC Class Codes: B29C 66/729 Textile or other fibrous material made from plastics
• CPC Class Codes: B29K 2623/12 PP, i.e. polypropylene
• CPC Class Codes: B29K 2713/00 Use of textile products or fabrics for preformed parts, e.g. for inserts B29K2105/06 takes precedence
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

A prosthesis including a support structure for enhancing kink and/or crush resistance. The support structure is connected to an outer surface of the prosthesis and includes at least two components, one of which has a lower melting point than the other. The component with the lower melting point is used to connect the support structure to the outer surface of the prosthesis.

Claims

1. An implantable prosthesis comprising:

(a) a generally tubular body comprising an outer textile surface; and

(b) a support structure attached to the outer textile surface of the body and configured to increase at least one of kink resistance and crush resistance of the body, the support structure comprising;

a first component; and

a second component, the second component (i) comprising a polymeric material, (ii) having a lower melting temperature than that of the first component and the body, and (iii) connecting the first component to the body; and

wherein prior to implantation a portion of the first component and a portion of the second component are removable with respect to the outer textile surface without substantially compromising the structural integrity of the outer textile surface upon removal.

2. The implantable prosthesis of claim 1, wherein the body of the implantable prosthesis comprises an inner layer made from a biocompatible polymer.

3. The implantable prosthesis of claim 2, wherein a portion of the support structure is configured to be removably attached to the outer textile layer such that removal of the portion of the first component relative to the outer textile layer removes portion of the second component while leaving a remainder of the second component connected to the outer textile layer.

4. The implantable prosthesis of claim 2, wherein a biocompatible elastomeric bonding agent bonds an outer surface of the inner layer to an inner surface of an outer textile layer.

5. The implantable prosthesis of claim 2, wherein the inner layer is made from at least one of ePTFE, polyurethane, silicone, and an acrylate.

6. The implantable prosthesis of claim 2, wherein the inner layer is made from ePTFE.

7. The implantable prosthesis of claim 1, wherein the outer textile surface is an outer surface of an outer textile layer comprising filaments or yarns with interstices or pores between them, wherein the second component extends into the interstices or pores and thereby mechanically connects the first component of the support structure to the outer textile layer such that connection between the support structure and the body is sufficiently strong to secure the support structure to the outer textile surface when the prosthesis is positioned in a patient'"'"'s body but also allows a portion of the support structure to be safely pulled off the outer textile surface so as to allow for sizing of the prosthesis or customizing a location of the support structure before implantation.

8. The implantable prosthesis of claim 7, wherein the outer textile layer comprises a knit, woven or braid pattern of the filaments or yarns and wherein the second component of the support structure is removably connected to the outer textile layer such that removal of the first component does not substantially damage the knit, woven or braid pattern.

9. The implantable prosthesis of claim 1, wherein the first component has a melting temperature of approximately 130°

C.-170°

C. and the second component has a melting temperature of approximately 60°

C.-105°

C.

10. The implantable prosthesis of claim 1, wherein the first component is made from polypropylene.

11. The implantable prosthesis of claim 1, wherein the second component is made from polyethylene.

12. The implantable prosthesis of claim 1, wherein the support structure is wrapped about the outer textile surface.

13. The implantable prosthesis of claim 1 wherein the second component is disposed about the first component.

14. The implantable prosthesis of claim 1, wherein the first component is co-extruded with the second component so as to be continuous with the second component.

15. The implantable prosthesis of claim 1, wherein the support structure is directly attached to the outer textile surface such that the second component is positioned between and connects the first component to the body.

16. The implantable prosthesis of claim 1, wherein the first component forms a core of the support structure and the second component at least partially encases the first component forming a complete or partial sheath around the first component.

17. An implantable prosthesis comprising:

a generally tubular body having a generally tubular configuration when inserted into a subject during implantation, wherein the body comprises an outer textile surface; and

a support structure disposed about the body, wherein the support structure comprises;

a first polymer component; and

a second polymer component secured to the first polymer component such that a portion of the second polymer component is in intimate contact with and located about a portion of the first polymer component thereby connecting the first polymer component to the body, wherein the second polymer component is different from the first polymeric component; and

wherein prior to implantation the portion of the first polymer component and the portion of the second polymer component are detachable with respect to the outer textile surface so as to be capable of being pulled off along a length of the outer textile surface without substantially damaging the outer textile surface and so as to facilitate cutting the prosthesis to a desired length or customizing a location of the support structure.

18. The implantable prosthesis of claim 17, wherein the second polymer component has a lower melting point than a melting point of the first polymer component and a melting point of the body.

19. The implantable prosthesis of claim 17, wherein the first polymer component forms a core of the support structure and the second polymer component at least partially encases the first polymer component forming a complete or partial sheath around the first polymer component.

21. The implantable prosthesis of claim 17, wherein the support structure is directly connected to the outer textile surface.

22. The implantable prosthesis of claim 17, wherein the first polymer component is polypropylene and wherein the second polymer component is polyethylene.

20. An implantable prosthesis comprising:

a generally tubular body comprising an outer textile surface; and

a support structure configured to increase at least one of kink resistance and crush resistance of the body, wherein the support structure comprises;

a first component; and

a second component connecting the first component to the body, wherein the second component comprises a polymeric material; and

wherein prior to implantation a portion of the support structure is safely detachable with respect to the outer textile surface such that a portion of the first component and a portion of the second component can be safely pulled off the outer textile surface so as to facilitate cutting the prosthesis to a desired length or customizing a location of the support structure.

23. The implantable prosthesis of claim 20, wherein removal of the portion of the support structure does not substantially damage the outer textile surface.

24. The implantable prosthesis of claim 20, wherein the second component has a lower melting point than a melting point of the first component and a melting point of the body.

25. The implantable prosthesis of claim 20, wherein removal of the portion of the support structure does not substantially damage the outer textile surface and wherein removal of the portion of the first component relative to the outer textile surface removes the portion of the second component while leaving a remainder portion of the second component connected to the outer textile surface.

26. The implantable prosthesis of claim 25, wherein the remainder portion of the second component is capable of withstanding a predetermined pulling force of 10 grams to 300 grams.

27. The implantable prosthesis of claim 20, wherein the first component forms a core of the support structure and the second component is configured as a sheath encasing the first component.

28. The implantable prosthesis of claim 20, wherein the support structure is configured as a composite polymer bead and wherein the first component comprises a polymer material different than the polymer material of the second component.

29. The implantable prosthesis of claim 20, wherein an end of the body is unsupported by the support structure.

30. The implantable prosthesis of claim 20, wherein the support member is disposed about and directly attached to the body without any additional means for attaching the support member to the body.

31. The implantable prosthesis of claim 20, wherein the body has a generally tubular configuration when inserted into a subject during implantation.